[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-reconstruction-after-mastectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-reconstruction-after-mastectomy":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,56,88,114,140,162],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100517128","post-market-prospective-clinical-study-of-nagor-perle-mammary-implants-100517128",false,"NCT06013514","Post-market Prospective Clinical Study of Nagor Perle Mammary Implants","A Prospective, Multi-center, Observational, Non Comparative, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Nagor PERLE Range of Silicone Breast Implants When Used in Breast Implantation","PERLE10PMCF","Inclusion Criteria:\n\n1. Genetic female subjects aged ≥18 and ≤65\n2. Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:-\n\ni) Primary breast reconstruction following mastectomy (both for one-stage or two-stage surgeries, including patients with previous radiotherapy and who have ADMs of animal origin (bovine, porcine)). ii) Primary breast augmentation (cosmetic surgery) with or without mastopexy iii) Breast revision surgery with or without mastopexy c) Subjects who have received a Nagor PERLE implant. d) Subjects who have provided informed consent and can adhere to the requirements of follow up appointments as per the study protocol.\n\nExclusion Criteria:\n\n1. Subjects undergoing implant augmentation with a BMI \\> 30 and undergoing reconstruction with a BMI \\>32.\n2. Subjects with autoimmune disease, lung fibrocystic disease, conditions that interfere with wound healing and blood clotting, a weakened immune system, reduced blood supply to the breast tissue or any other condition for which breast implants are contraindicated.\n3. Subjects who have participated in a clinical study which involve chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer related clinical studies.\n4. Subjects with insufficient tissue covering due to either radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.\n5. Subjects who have ADMs of synthetic origin.\n6. Subjects who, in the Investigator's clinical opinion, have existing local or metastatic carcinoma of the breast that is unlikely to be fully excised at the time of insertion of the breast implant.\n7. Subjects with known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery.\n8. Subjects with an active infection who are unsuitable for surgery unless, in the opinion of the investigator, they are treated and cleared by the investigator.\n9. Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery.\n10. Subjects with a known history of compromised wound healing.\n11. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.\n12. Women who are pregnant and\u002For current breast feeders who do not stop breast feeding within 3 months of getting breast implants\n13. Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant","FEMALE","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","OBSERVATIONAL","Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to maintain a record of safety and performance with all medical implants.\n\nThis study is designed to collect data on a new generation of smooth mammary implants to assess the long term performance and safety data on this type of gel-filled mammary breast implant.\n\nThe two main complications of breast implants are capsular contracture and rupture; these complications can take years to develop. The study is designed to evaluate the occurrence of these two primary complication as well as other secondary complications over a period of 10 years. Patient follow up will be carried out pre-operatively and post operatively at 12 months and then 3, 5, 8 and 10 years thereafter.\n\nThe study will be carried out over 10 years to adequately assess complications which may only occur over the lifetime of the device such as systemic complications",[26,27,28,29,30,31,32,33],"Breast Reconstruction","Breast Reconstruction Following Mastectomy","Breast Revision","Breast Augmentation","Breast Reconstruction With Silicone Implants","Breast Reconstruction After Mastectomy","Breast Reconstruction Surgery","Breast Implants",[35,36,37,38,39,40,41,42],"prospective","observational","non-comparative","post-marketing study","PMCF","Perle","Nagor","GCA","RECRUITING","2026-06-25",{"date":46,"type":47},"2026-06-29","ACTUAL",{"date":49,"type":47},"2024-06-01",{"date":51,"type":22},"2038-09",{"name":53,"class":54},"GCA (Eurosilicone)","INDUSTRY",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":55},"100643509","autologous-fat-grafting-for-total-breast-reconstruction-in-irradiated-breast-cancer-patients-100643509","NCT07641985","Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients","Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Patients","AFT-R","Inclusion Criteria:\n\n* Female, aged \\>18 years.\n* BMI between \\> 22 and \\\u003C35 kg\u002Fm2\n* History of breast cancer treated with mastectomy (minimally 3 months after mastec-tomy) and post mastectomy chest wall radiotherapy (completed ≥6 months before en-rollment).\n* May include contralateral\u002Fbilateral prophylactic mastectomy if at least one side had cancer and radiation.\n* Desires autologous breast reconstruction and accepts randomization between AFT and DIEP.\n* Medically fit for surgery (ASA I-III).\n* Sufficient donor tissue for both AFT (enough fat) and DIEP (suitable abdominal tissue and vasculature).\n* No evidence of active cancer at enrollment; remission confirmed.\n* Able to wear the EVE device (if randomized in AFT).\n* Capable of understanding study information and questionnaires (Dutch or English), willing to give informed consent, and able to comply with follow-up.\n\nExclusion Criteria:\n\n* Prior autologous breast reconstruction on the intended side. BMI \\\u003C22 or \\>35 kg\u002Fm2\n* Contraindication to DIEP flap (e.g., prior abdominoplasty or abdominal scars affecting perforators).\n* Contraindication to AFT (e.g., insufficient fat or conditions impairing fat graft viability).\n* Current chemotherapy or completed less than 4 weeks prior to enrollment.\n* Serious uncontrolled comorbidities making elective surgery unsafe (e.g., unstable heart disease, severe coagulopathy, end-stage organ failure).\n* Active smoker or not abstinent for at least 6 weeks pre-operatively.\n* Pregnant at time of enrollment.\n* In case low compliance is expected or an inability to comply with study protocol, including unwillingness to undergo either AFT or DIEP, or inability to complete follow-up (due to language, cognitive issues, or relocation plans).\n* Previous enrollment in this trial (patients can only be included once, even if later presenting for contralateral reconstruction).\n* Allergy to lidocaine or silicone",{"count":65,"type":22},280,"INTERVENTIONAL",[68],"NA","The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following mastectomy. It will also evaluate patient satisfaction, quality of life, complication rates, and cost-effectiveness of both reconstruction techniques. The main questions it aims to answer are:\n\nDoes AFT result in non-inferior patient satisfaction with the reconstructed breast compared to DIEP flap reconstruction 12 months after the final operation? Does AFT result in fewer major complications and improved cost-effectiveness compared to DIEP flap reconstruction? Are quality of life outcomes and oncologic safety comparable between AFT and DIEP flap reconstruction in irradiated patients?\n\nResearchers will compare AFT to DIEP flap reconstruction to see if AFT can provide similar reconstructive outcomes with lower morbidity and fewer complications in irradiated breast cancer patients.\n\nParticipants will:\n\nUndergo breast reconstruction using either AFT or DIEP flap reconstruction Attend follow-up visits for clinical examinations, imaging, and assessment of complications Complete questionnaires about breast satisfaction, quality of life, and recovery during follow-up Be monitored for oncologic safety and reconstructive outcomes for 12 months after the final operation",[71,26,31,72,73],"Breast Cancer","Breast Cancer Radiation","Lipofilling",[73,75,76],"Breast reconstruction","Irradiated patients","NOT_YET_RECRUITING","2026-06-09",{"date":80,"type":47},"2026-06-11",{"date":82,"type":22},"2026-07-01",{"date":84,"type":22},"2032-07-01",{"name":86,"class":87},"Maastricht University Medical Center","OTHER",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100643334","a-comparative-study-of-delayed-endoscopic-dti-and-autologous-flap-reconstruction-post-mastectomy-100643334","NCT07602868","A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-Mastectomy","A National Multicenter, Prospective, Cohort Study on Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Transaxillary Approach Versus Autologous Flap Breast Reconstruction Following Mastectomy","DEDIA","Inclusion Criteria:\n\n* Female patients aged 18-70 years\n* One year after Modified Radical Mastectomy (MRM), Nipple-Sparing Mastectomy (NSM), or Skin-Sparing Mastectomy (SSM), or six months after the completion of radiotherapy, provided the local skin remains viable and sufficiently lax;\n* voluntary participation and ability to provide written informed consent.\n\nExclusion Criteria:\n\n* History of breast surgery in which the pectoralis major muscle was removed;\n* Patients with serious preoperative co-morbidities and poor general condition who cannot tolerate the surgery;\n* Diabetes mellitus with a long history of smoking or combined poor glycemic control;\n* current enrollment in other clinical trials that may interfere with study outcomes;\n* Review (clinical, imaging, pathological basis) reveals the presence of local\u002Fregional recurrence or uncontrollable distant metastasis.","70 Years",{"count":98,"type":22},588,"In China, low breast-conserving surgery rates and historically minimal immediate reconstruction following mastectomy have resulted in a significant population of women living without a breast, often leading to long-term psychosocial distress. Current delayed reconstruction options are limited: traditional two-stage implant reconstruction necessitates two surgeries with associated costs and risks like infection and implant exposure, while autologous tissue transfer (e.g., TRAM\u002FDIEP flaps), though offering superior natural aesthetics and patient satisfaction, involves extensive donor-site morbidity, prolonged recovery, and significant scarring, restricting its suitability. To address the drawbacks of both established methods-significant trauma, cost, and complexity-this study evaluates a novel technique for breast cancer patients post-mastectomy: endoscopic delayed direct-to-implant breast reconstruction. This study proposes to conduct a prospective cohort study to analyze complication rates, breast aesthetic scores, quality of life metrics, and other dimensions between delayed direct-to-implant breast reconstruction and abdominal flap breast reconstruction（DIEP and TRAM). The aim is to comprehensively evaluate the safety and clinical feasibility of endoscopic delayed direct-to-implant breast reconstruction.",[31],[102,103,104],"delayed Endoscopic DTI","DIEP","TRAM","2026-06-08",{"date":107,"type":47},"2026-06-10",{"date":109,"type":22},"2026-09-01",{"date":111,"type":22},"2030-12-31",{"name":113,"class":87},"West China Hospital",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":121,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":66,"phases":124,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":55},"100632653","thermal-preconditioning-in-mastectomy-patients-with-immediate-breast-reduction-100632653","NCT07516483","Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction","Thermal Preconditioning in Patients Undergoing Mastectomy With Planned Immediate Breast Reconstruction: A Randomized Feasibility Trial","Inclusion Criteria:\n\n* Adult patients (≥ 18 years of age) undergoing prophylactic or therapeutic mastectomy with planned immediate breast reconstruction at Atrium Health Wake Forest Baptist Medical Center.\n\nExclusion Criteria:\n\n* Patients with no plan for any breast reconstruction.\n* Patients with inflammatory breast cancer.\n* History of any radiation to the breast or chest wall.\n* Patients with pre-existing local dermatological conditions.\n* Patients belonging to vulnerable populations (e.g., children, pregnant individuals, incarcerated persons).\n* Patients unable to provide informed consent or comply with study procedures.","ALL",{"count":123,"type":22},40,[68],"The purpose of this research study is to understand patient experiences and the feasibility of using a breast heat preconditioning device (Plexaa BLOOM43), designed to improve postoperative outcomes when used prior to mastectomy and breast reconstruction.",[31],[128,129,130],"heat preconditioning","mastectomy","breast reconstruction","2026-05-22",{"date":133,"type":47},"2026-05-26",{"date":135,"type":22},"2026-07",{"date":137,"type":22},"2027-05",{"name":139,"class":87},"Wake Forest University Health Sciences",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":96,"enrollmentInfo":147,"targetDuration":4,"studyType":66,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":158,"leadSponsor":160,"locationsCount":55},"100621026","study-on-the-cosmetic-outcome-and-safety-evaluation-of-3d-printed-biodegradable-biological-mesh-for-one-stage-breast-reconstruction-after-radical-mastectomy-100621026","NCT07365267","Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy","Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy :A Prospective, Single-Center, Single-Arm Clinical Study","Inclusion Criteria:\n\n* Female breast cancer patients aged 18 to 70 years.\n* Histopathologically confirmed invasive breast cancer, as defined by the latest ASCO\u002FNCCN guidelines.\n* Unable to undergo breast-conserving surgery or willing to undergo total mastectomy with immediate implant-based breast reconstruction.\n* ECOG performance status of 0-1.\n* Voluntary participation in the study and signing of the written informed consent form.\n\nExclusion Criteria:\n\n* Age \\>70 years.\n* Metastatic breast cancer (Stage IV) at initial diagnosis.\n* Multicentric, extensive, diffuse lesions, or inflammatory breast cancer.\n* Tumor involvement of the nipple-areolar complex.\n* Breast cancer during pregnancy.\n* History of other malignancies within the past 5 years, except for cured cervical carcinoma in situ or non-melanoma skin cancer.\n* Abnormal function of vital organs such as heart, lungs, liver, or kidneys; poorly controlled diabetes, etc., rendering the patient unable to tolerate surgery.\n* Patients deemed unsuitable for participation by the investigator.",{"count":148,"type":22},25,[68],"Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction. The study targets adult women undergoing total mastectomy for breast cancer followed by implant-based reconstruction. It aims to determine the utility of the 3D-printed biodegradable mesh in implant-based breast reconstruction, assess its influence on tissue regeneration, postoperative cosmetic result, and complication profile.",[71,31,152],"3D-Printed Biodegradable Biological Mesh",[152,130],"2026-01-15",{"date":156,"type":47},"2026-01-26",{"date":154,"type":22},{"date":159,"type":22},"2028-12-01",{"name":161,"class":87},"Xijing Hospital",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":66,"phases":171,"briefSummary":172,"conditions":173,"keywords":179,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":187,"leadSponsor":189,"locationsCount":55},"100616643","longitudinal-evaluation-of-direct-neurotization-technique-in-breast-reconstruction-with-fully-autologous-components-100616643","NCT07308275","Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components","Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components: An Assessment of BREAST-Q Sensation Module, Cutaneous Pressure Threshold, Neuregulin 1 (NRG1) Expression, Nerve Fiber Cross-sectional Area, Intraepidermal Nerve Fiber Density (IENFD), and Breast Morphometry","Inclusion Criteria:\n\n* Female patients aged ≥18 years.\n* Patients with unilateral breast cancer who have undergone or will undergo unilateral mastectomy.\n* Patients undergoing breast reconstruction.\n* Patients with unilateral breast cancer regardless of adjuvant therapy status (receiving radiotherapy and\u002For chemotherapy or receiving no adjuvant therapy).\n* Willing to comply with all scheduled examinations and tissue sampling procedures.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* History of peripheral neuropathy (e.g., diabetes mellitus with neuropathic complications).\n* Bilateral mastectomy.\n* Presence of skin or soft-tissue conditions of the breast that may interfere with sensory assessment.\n* Active smokers (use of tobacco, vape, or other nicotine products within 14 days prior to neurotization).\n* Refusal or inability to attend follow-up evaluations.",{"count":170,"type":22},28,[68],"This clinical trial aims to evaluate whether direct neurotization using fully autologous components during autologous breast reconstruction improves postoperative breast sensation and sensory-related quality of life in women undergoing unilateral mastectomy. Direct neurotization involves coapting the recipient intercostal nerve to an autologous nerve graft placed within the flap to facilitate reinnervation.\n\nThe study's primary questions are:\n\n1. Does direct neurotization using fully autologous nerve grafts improve cutaneous sensory recovery, as assessed by Semmes-Weinstein monofilament thresholds measured at standardized breast locations?\n2. Does neurotization enhance patient-reported sensory outcomes and quality of life, as assessed by the BREAST-Q Sensation Module?\n\nAs secondary objectives, the study will assess whether biological predictors of nerve regeneration correlate with sensory outcomes. These include:\n\n1. Neuregulin-1 (NRG1) expression in flap tissue biopsy;\n2. Cross-sectional area of the recipient nerve fibres;\n3. Breast morphometry measured at baseline and follow-up;\n4. Intraepidermal nerve fibre density (IENFD) on skin biopsy.\n\nParticipants will be randomly assigned to receive either:\n\n1. Neurotized autologous breast reconstruction using fully autologous graft components, or\n2. Standard (non-neurotized) autologous breast reconstruction.\n\nThe study will compare these groups to determine whether neurotization accelerates or enhances the return of breast sensation over a 6-month follow-up period, with evaluations at 1 month, 3 months, and 6 months after surgery.\n\nParticipants will undergo:\n\n1. Autologous breast reconstruction with or without direct neurotization as part of their planned cancer surgery.\n2. Sensory testing using Semmes-Weinstein monofilaments at baseline, 1, 3, and 6 months.\n3. Completion of BREAST-Q questionnaires evaluating breast sensation, symptoms, and quality of life at each follow-up visit.\n\n3\\. Intraoperative tissue sampling for NRG1 analysis and nerve morphometry. 4. Skin biopsy (if applicable) to assess intraepidermal nerve fibre density. 5. Breast morphometry assessment using a breast morphometry measurement software tool.\n\nThis study seeks to provide high-quality evidence on the effectiveness of direct neurotization using fully autologous components in restoring breast sensation and to explore biological predictors that may influence sensory recovery after autologous breast reconstruction.",[31,174,175,176,177,178],"Neurotization","Mastectomy and Breast Reconstruction","Peripheral Nerve Regeneration","Sensory Function","Quality of Life (QOL)",[180,129,181,182],"breast neurotization","breast sensory","quality of life","2025-12-15",{"date":185,"type":47},"2025-12-29",{"date":183,"type":22},{"date":188,"type":22},"2027-04-15",{"name":190,"class":87},"Fakultas Kedokteran Universitas Indonesia"]